Treatment as Prevention (TasP) in the UK supports access to ART at any CD4 count

1 February 2016. Related: Treatment access.

Simon Collins, HIV i-Base

It is a significant advance that since July 2015 the NHS has funded antiretroviral HIV treatment (ART) to reduce the risk of further HIV transmission – commonly referred to as Treatment as Prevention (TasP). [1]

Luckily this policy also enables broad access to ART irrespective of CD4 count, bringing the UK in-line with BHIVA, US, European and WHO treatment guidelines.

Currently, HIV commissioners are attempting to enforce a policy that restricts access to HIV treatment until CD4 cells count dropped to 350 cells/mm³ even though BHIVA clinical guidelines in 2015 recommend treatment irrespective of CD4 count.

Criteria for commissioning TasP

The Clinical Reference Group (CRG) policy from NHS England lists the following criteria for routinely commissioning of TasP, with expectations that all of the criteria below are met.

• Laboratory confirmed diagnosis of HIV infection.
• Sexually active.
• TasP is offered by the doctor.
• Discussion between doctor and patient has identified significant risk of HIV transmission to partners without TasP.
• TasP is prescribed as part of a full assessment of risk factors by the clinical team and is part of a risk reduction plan discussed with the patient.
• Patient has considered the information relating to TasP and understands the risks and benefits of treatment to prevent onward HIV transmission.
• Regimen selected is the lowest cost, clinically appropriate option.

While many of these are not controversial and others seem reasonable, the exact wording is unspecific on some issues, allowing doctors to broadly interpret risk in favour of earlier access to ART.

Interpreting CRG policy

The TasP policy effectively enables all HIV positive people in the UK to access ART, and overcomes an access issue that denies the clinical benefits of ART to people at higher CD4 counts.

Although the policy enables access to ART, the rationale for approval uses language that underestimates the difficulties that most HIV positive people experience.

• Requiring that a person is sexually active ignores the not uncommon decision that many HIV positive people take to abstain from sex, largely on the basis of protecting sexual partners. The requirement for “current” partners in the policy underestimates the continued stigma and prejudice against HIV positive people from HIV negative (or untested) potential partners.
  On both these points the real benefit of TasP should be to support HIV positive people to be able to develop and sustain relationships; but TasP is the essential first step that helps enable this, not the final one. TasP is needed in order to enable people to start to rebuild a health sex life.
• The phrase “identifying significant risk” needs to be broadly interpreted. Significant risk is actually covered by the potential for a condom to break or even the fear that a condom might break. It is very unlikely that the policy requires HIV positive people to say they currently put partners at risk in order to access ART (for either prevention or treatment).
• Current treatment guidelines already cover the cost of treatment in relation to clinical evidence, and the appropriate referral should have been to clinical guidelines, not a reference to cost.

Comment

The TasP policy from July 2015 is an essential document for people whose CD4 counts are higher than 350 cells/mm3 and who are otherwise currently excluded from receiving ART based on current commissioning policy. The limited financial impact from the policy is recognised in the document as most HIV positive people who are diagnosed are already on ART.

TasP overcomes a gap between UK clinical guidelines and commissioning policy. BHIVA HIV treatment guidelines, accredited by NICE, recommend that all HIV positive people should start ART for clinical benefits, irrespective of their CD4 count and yet commissioning for earlier ART would not produce changes in policy for at least two years. [2]

NHS commissioners have so far refused to prioritise earlier ART based on results from the START study in July 2015. [3] These results were so significant that the World Health Organisation (WHO) issued a statement within weeks indicating that WHO guidelines would change. [4, 5] Based on results from the START study US guidelines have strengthened the evidence rating for universal ART and European guidelines have removed the CD4 threshold criteria. [6, 7]

Luckily, the NHS allows sufficient flexibility for ART to now be prescribed to all HIV positive people using the TasP policy, irrespective of the current risk of transmission.

References:

1. Specialised Commissioning Team, NHS England. Treatment as Prevention in HIV infected adults (F03/P/c). July 2015).
   https://www.england.nhs.uk/commissioning/wp-content/uploads/sites/12/2015/10/f03pc-tasp-oct15.pdf (PDF)
2. BHIVA guidelines for the treatment of HIV-1-positive adults with antiretroviral therapy (2015). BHIVA.
   http://www.bhiva.org/HIV-1-treatment-guidelines.aspx
   http://www.bhiva.org/documents/Guidelines/Treatment/2015/2015-treatment-guidelines.pdf (PDF)
3. Lundgren J et al. Initiation of antiretroviral therapy in early asymptomatic infection. NEJM (20 July 2015). DOI: 10.1056/NEJMoa1506816.
   http://www.nejm.org/doi/full/10.1056/NEJMoa1506816
4. Clayden P. New directions in the 2015 WHO ART guidelines. HTB August 2015.
   https://i-base.info/htb/28597
5. WHO. Policy brief. Consolidated guidelines on the use of ARVs for treating and preventing HIV infection: what’s new. November 2015.
   http://www.who.int/hiv/pub/arv/policy-brief-arv-2015/en
6. US DHHS. Guidelines for the use of antiretroviral agents in HIV-1-infected adults and adolescents. (January 2016).
   https://aidsinfo.nih.gov/guidelines
7. European AIDS Clinical Society. Guidelines. Version 8.0, October 2015. English edition.
   http://www.eacsociety.org/guidelines/eacs-guidelines/eacs-guidelines.html